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Trial record 57 of 186 for:    BUPRENORPHINE AND NALOXONE

Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03420313
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : May 3, 2019
Information provided by (Responsible Party):
Stacey C. Sigmon, University of Vermont

Brief Summary:
Despite the demonstrated effectiveness of agonist treatment for opioid dependence and alarming recent increases in overdose deaths, waiting lists for treatment persist. In a Behavioral & Integrative Treatment Development pilot study, the investigators demonstrated the initial efficacy a novel Interim Buprenorphine Treatment (IBT) to mitigate the risks (e.g., illicit opioid use, IV drug use) associated with treatment delays. However, consistent with that R34 mechanism, our initial pilot study involved a limited sample size and was conducted at a single academic, well-controlled research clinic with an extensive history of research. It is important to replicate these very positive pilot results and begin to evaluate whether they generalize to less-controlled rural environments that are being so adversely impacted by the current opioid abuse epidemic. In this Stage II randomized parallel two-group trial, the investigators will evaluate the efficacy of IBT using a larger sample of 100 waitlisted opioid-dependent adults (50 IBT, 50 WLC). UVM will serve as the coordinating center and we will aim to partner with health centers and other convenience sites in rural Vermont counties to conduct study visits while overcoming barriers commonly encountered in rural areas (e.g., transportation issues, socioeconomic barriers). The proposed research builds directly on the promising Stage I results and has the potential to substantially reduce the vast individual and societal costs associated with opioid treatment delays.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Buprenorphine/naloxone sublingual tablets Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized parallel two-group trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Interim Buprenorphine Treatment

Interim Buprenorphine Treatment includes (a) Maintenance treatment with Buprenorphine/ naloxone sublingual tablets with bi-monthly clinic visits for observed dosing and the remaining doses dispensed at home via a secure computerized portable device (Med-O-Wheel, Addoz, Finland).

(b) nightly calls from an automated Interactive Voice Response (IVR) phone system to assess any drug use, withdrawal and craving, (c) IVR-generated random call-backs for urinalysis and pill counts, and (d) HIV+Hepatitis education delivered via iPad. (e) monthly follow-up assessments

Drug: Buprenorphine/naloxone sublingual tablets
24-week maintenance with buprenorphine/naloxone sublingual tablets (plus other technology-assisted components described previously)
Other Name: BUP

No Intervention: Waitlist Control
Waitlist Control participants will remain on the waitlist for their treatment of choice but complete the same monthly assessments.

Primary Outcome Measures :
  1. Illicit opioid abstinence [ Time Frame: 12 weeks ]
    Overall percentage of urinalyses biochemically verified to be abstinent for illicit opioids during the treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • For inclusion, participants must be >=18 years old, in good health, meet DSM-V criteria for opioid use disorder, provide an opioid-positive urine and be currently waitlisted with a community opioid treatment clinic or provider.

Exclusion Criteria:

  • Those with a significant psychiatric or medical illness that may interfere with consent or participation will be excluded, as will those who are pregnant or nursing. Those dependent on sedative-hypnotics will be excluded, due to the medical risks and notably low success rates with sedative-dependent opioid abusers (Stitzer & Chutuape, 1999).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03420313

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Contact: Stacey C Sigmon, PhD 802-656-9987

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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Stacey C Sigmon, PhD    802-656-9987   
Contact: Susan Enos    802-656-8712   
Sponsors and Collaborators
University of Vermont

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Responsible Party: Stacey C. Sigmon, Associate Professor, UVM Dept of Psychiatry, University of Vermont Identifier: NCT03420313     History of Changes
Other Study ID Numbers: 1R01DA042790-01 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stacey C. Sigmon, University of Vermont:
interim treatment
opioid use disorder
Additional relevant MeSH terms:
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Buprenorphine, Naloxone Drug Combination
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists